private:tenzinggroup-2
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2813376
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Jun 3rd, 2019 12:00AM
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Tenzing Group, LLC
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9
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0.00
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Open
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Hospital & Health Care
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Jun 3rd, 2019 07:17PM
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Jun 3rd, 2019 07:17PM
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Discounting future regulatory costs is extremely dangerous for start-up developers. By not preparing for the cost of 510(k) approval in addition to the added time for product deployment, these start-ups are ignoring a burden that could ultimately cost them their company. The Tenzing Group, LLC, can help these start-ups navigate the massive and confusing landscape that is the FDA. Using current regulations, our regulatory review will first analyze the mobile medical application's (MMA's) stance within the FDA and provide quality feedback on whether their product currently falls under FDA jurisdiction. Next, we will discuss potential FDA regulation, using draft guidance and other materials alluding to the FDA’s stance, which could bring the MMA into the guise of the FDA. Once we make our conclusions about regulation we then will inform the company about the costs associated with FDA compliance and approval and ways to mitigate those costs through implementing FDA mandated practices in the early stages of development. Finally, using data obtained through client interviews, we will offer best business practices and marketing strategies that will help alleviate the regulatory burden. This report will supply the start-up and any potential investors with the valuable information needed to prepare for the FDA, thus giving them a leg-up over their competitors and helping to create a sustainable and profitable business that will succeed despite regulation.
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Open
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Regulatory Affairs, Mobile Health, Mobile Medical Applications, Legislative Affairs
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Open
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P.O. Box 356
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Santa Clara
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CA
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US
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95052
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Tenzing Group
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Pharmaceuticals & Biotechnology
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private:tenzinggroup-2
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2813376
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Mar 23rd, 2018 12:00AM
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Tenzing Group, LLC
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9
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0.00
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Open
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Hospital & Health Care
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Mar 23rd, 2017 10:51AM
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Mar 23rd, 2017 10:51AM
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Discounting future regulatory costs is extremely dangerous for start-up developers. By not preparing for the cost of 510(k) approval in addition to the added time for product deployment, these start-ups are ignoring a burden that could ultimately cost them their company. The Tenzing Group, LLC, can help these start-ups navigate the massive and confusing landscape that is the FDA. Using current regulations, our regulatory review will first analyze the mobile medical application's (MMA's) stance within the FDA and provide quality feedback on whether their product currently falls under FDA jurisdiction. Next, we will discuss potential FDA regulation, using draft guidance and other materials alluding to the FDA’s stance, which could bring the MMA into the guise of the FDA. Once we make our conclusions about regulation we then will inform the company about the costs associated with FDA compliance and approval and ways to mitigate those costs through implementing FDA mandated practices in the early stages of development. Finally, using data obtained through client interviews, we will offer best business practices and marketing strategies that will help alleviate the regulatory burden. This report will supply the start-up and any potential investors with the valuable information needed to prepare for the FDA, thus giving them a leg-up over their competitors and helping to create a sustainable and profitable business that will succeed despite regulation.
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Tenzing Group
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Pharmaceuticals & Biotechnology
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private:tenzinggroup-2
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2813376
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Feb 17th, 2018 12:00AM
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Tenzing Group, LLC
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9
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0.00
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Open
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Hospital & Health Care
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Feb 17th, 2018 02:25PM
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Feb 17th, 2018 02:25PM
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Discounting future regulatory costs is extremely dangerous for start-up developers. By not preparing for the cost of 510(k) approval in addition to the added time for product deployment, these start-ups are ignoring a burden that could ultimately cost them their company. The Tenzing Group, LLC, can help these start-ups navigate the massive and confusing landscape that is the FDA. Using current regulations, our regulatory review will first analyze the mobile medical application's (MMA's) stance within the FDA and provide quality feedback on whether their product currently falls under FDA jurisdiction. Next, we will discuss potential FDA regulation, using draft guidance and other materials alluding to the FDA’s stance, which could bring the MMA into the guise of the FDA. Once we make our conclusions about regulation we then will inform the company about the costs associated with FDA compliance and approval and ways to mitigate those costs through implementing FDA mandated practices in the early stages of development. Finally, using data obtained through client interviews, we will offer best business practices and marketing strategies that will help alleviate the regulatory burden. This report will supply the start-up and any potential investors with the valuable information needed to prepare for the FDA, thus giving them a leg-up over their competitors and helping to create a sustainable and profitable business that will succeed despite regulation.
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Tenzing Group
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Pharmaceuticals & Biotechnology
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private:tenzinggroup-2
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2813376
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Feb 16th, 2018 12:00AM
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Tenzing Group, LLC
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9
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0.00
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Open
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Hospital & Health Care
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Feb 16th, 2017 08:15AM
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Feb 16th, 2017 08:15AM
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Discounting future regulatory costs is extremely dangerous for start-up developers. By not preparing for the cost of 510(k) approval in addition to the added time for product deployment, these start-ups are ignoring a burden that could ultimately cost them their company. The Tenzing Group, LLC, can help these start-ups navigate the massive and confusing landscape that is the FDA. Using current regulations, our regulatory review will first analyze the mobile medical application's (MMA's) stance within the FDA and provide quality feedback on whether their product currently falls under FDA jurisdiction. Next, we will discuss potential FDA regulation, using draft guidance and other materials alluding to the FDA’s stance, which could bring the MMA into the guise of the FDA. Once we make our conclusions about regulation we then will inform the company about the costs associated with FDA compliance and approval and ways to mitigate those costs through implementing FDA mandated practices in the early stages of development. Finally, using data obtained through client interviews, we will offer best business practices and marketing strategies that will help alleviate the regulatory burden. This report will supply the start-up and any potential investors with the valuable information needed to prepare for the FDA, thus giving them a leg-up over their competitors and helping to create a sustainable and profitable business that will succeed despite regulation.
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Tenzing Group
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Pharmaceuticals & Biotechnology
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private:tenzinggroup-2
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2813376
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Feb 15th, 2018 12:00AM
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Tenzing Group, LLC
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9
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0.00
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Open
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Hospital & Health Care
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Feb 15th, 2017 10:07AM
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Feb 15th, 2017 10:07AM
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Discounting future regulatory costs is extremely dangerous for start-up developers. By not preparing for the cost of 510(k) approval in addition to the added time for product deployment, these start-ups are ignoring a burden that could ultimately cost them their company. The Tenzing Group, LLC, can help these start-ups navigate the massive and confusing landscape that is the FDA. Using current regulations, our regulatory review will first analyze the mobile medical application's (MMA's) stance within the FDA and provide quality feedback on whether their product currently falls under FDA jurisdiction. Next, we will discuss potential FDA regulation, using draft guidance and other materials alluding to the FDA’s stance, which could bring the MMA into the guise of the FDA. Once we make our conclusions about regulation we then will inform the company about the costs associated with FDA compliance and approval and ways to mitigate those costs through implementing FDA mandated practices in the early stages of development. Finally, using data obtained through client interviews, we will offer best business practices and marketing strategies that will help alleviate the regulatory burden. This report will supply the start-up and any potential investors with the valuable information needed to prepare for the FDA, thus giving them a leg-up over their competitors and helping to create a sustainable and profitable business that will succeed despite regulation.
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Tenzing Group
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Pharmaceuticals & Biotechnology
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private:tenzinggroup-2
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2813376
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Feb 14th, 2018 12:00AM
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Tenzing Group, LLC
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9
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0.00
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Open
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Hospital & Health Care
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Feb 14th, 2017 01:50PM
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Feb 14th, 2017 01:50PM
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Discounting future regulatory costs is extremely dangerous for start-up developers. By not preparing for the cost of 510(k) approval in addition to the added time for product deployment, these start-ups are ignoring a burden that could ultimately cost them their company. The Tenzing Group, LLC, can help these start-ups navigate the massive and confusing landscape that is the FDA. Using current regulations, our regulatory review will first analyze the mobile medical application's (MMA's) stance within the FDA and provide quality feedback on whether their product currently falls under FDA jurisdiction. Next, we will discuss potential FDA regulation, using draft guidance and other materials alluding to the FDA’s stance, which could bring the MMA into the guise of the FDA. Once we make our conclusions about regulation we then will inform the company about the costs associated with FDA compliance and approval and ways to mitigate those costs through implementing FDA mandated practices in the early stages of development. Finally, using data obtained through client interviews, we will offer best business practices and marketing strategies that will help alleviate the regulatory burden. This report will supply the start-up and any potential investors with the valuable information needed to prepare for the FDA, thus giving them a leg-up over their competitors and helping to create a sustainable and profitable business that will succeed despite regulation.
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Tenzing Group
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Pharmaceuticals & Biotechnology
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private:tenzinggroup-2
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2813376
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Feb 13th, 2018 12:00AM
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Tenzing Group, LLC
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9
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0.00
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Open
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Hospital & Health Care
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Feb 13th, 2017 04:11PM
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Feb 13th, 2017 04:11PM
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Discounting future regulatory costs is extremely dangerous for start-up developers. By not preparing for the cost of 510(k) approval in addition to the added time for product deployment, these start-ups are ignoring a burden that could ultimately cost them their company. The Tenzing Group, LLC, can help these start-ups navigate the massive and confusing landscape that is the FDA. Using current regulations, our regulatory review will first analyze the mobile medical application's (MMA's) stance within the FDA and provide quality feedback on whether their product currently falls under FDA jurisdiction. Next, we will discuss potential FDA regulation, using draft guidance and other materials alluding to the FDA’s stance, which could bring the MMA into the guise of the FDA. Once we make our conclusions about regulation we then will inform the company about the costs associated with FDA compliance and approval and ways to mitigate those costs through implementing FDA mandated practices in the early stages of development. Finally, using data obtained through client interviews, we will offer best business practices and marketing strategies that will help alleviate the regulatory burden. This report will supply the start-up and any potential investors with the valuable information needed to prepare for the FDA, thus giving them a leg-up over their competitors and helping to create a sustainable and profitable business that will succeed despite regulation.
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Tenzing Group
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Pharmaceuticals & Biotechnology
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private:tenzinggroup-2
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2813376
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Feb 12th, 2018 12:00AM
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Tenzing Group, LLC
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9
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0.00
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Open
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Hospital & Health Care
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Feb 12th, 2017 04:15AM
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Feb 12th, 2017 04:15AM
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Discounting future regulatory costs is extremely dangerous for start-up developers. By not preparing for the cost of 510(k) approval in addition to the added time for product deployment, these start-ups are ignoring a burden that could ultimately cost them their company. The Tenzing Group, LLC, can help these start-ups navigate the massive and confusing landscape that is the FDA. Using current regulations, our regulatory review will first analyze the mobile medical application's (MMA's) stance within the FDA and provide quality feedback on whether their product currently falls under FDA jurisdiction. Next, we will discuss potential FDA regulation, using draft guidance and other materials alluding to the FDA’s stance, which could bring the MMA into the guise of the FDA. Once we make our conclusions about regulation we then will inform the company about the costs associated with FDA compliance and approval and ways to mitigate those costs through implementing FDA mandated practices in the early stages of development. Finally, using data obtained through client interviews, we will offer best business practices and marketing strategies that will help alleviate the regulatory burden. This report will supply the start-up and any potential investors with the valuable information needed to prepare for the FDA, thus giving them a leg-up over their competitors and helping to create a sustainable and profitable business that will succeed despite regulation.
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Tenzing Group
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Pharmaceuticals & Biotechnology
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private:tenzinggroup-2
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2813376
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Feb 11th, 2018 12:00AM
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Tenzing Group, LLC
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9
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0.00
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Open
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Hospital & Health Care
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Feb 11th, 2017 05:35AM
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Feb 11th, 2017 05:35AM
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Discounting future regulatory costs is extremely dangerous for start-up developers. By not preparing for the cost of 510(k) approval in addition to the added time for product deployment, these start-ups are ignoring a burden that could ultimately cost them their company. The Tenzing Group, LLC, can help these start-ups navigate the massive and confusing landscape that is the FDA. Using current regulations, our regulatory review will first analyze the mobile medical application's (MMA's) stance within the FDA and provide quality feedback on whether their product currently falls under FDA jurisdiction. Next, we will discuss potential FDA regulation, using draft guidance and other materials alluding to the FDA’s stance, which could bring the MMA into the guise of the FDA. Once we make our conclusions about regulation we then will inform the company about the costs associated with FDA compliance and approval and ways to mitigate those costs through implementing FDA mandated practices in the early stages of development. Finally, using data obtained through client interviews, we will offer best business practices and marketing strategies that will help alleviate the regulatory burden. This report will supply the start-up and any potential investors with the valuable information needed to prepare for the FDA, thus giving them a leg-up over their competitors and helping to create a sustainable and profitable business that will succeed despite regulation.
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Tenzing Group
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Pharmaceuticals & Biotechnology
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private:tenzinggroup-2
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2813376
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Feb 10th, 2018 12:00AM
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Tenzing Group, LLC
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9
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0.00
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Open
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Hospital & Health Care
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Feb 10th, 2017 06:43AM
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Feb 10th, 2017 06:43AM
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Discounting future regulatory costs is extremely dangerous for start-up developers. By not preparing for the cost of 510(k) approval in addition to the added time for product deployment, these start-ups are ignoring a burden that could ultimately cost them their company. The Tenzing Group, LLC, can help these start-ups navigate the massive and confusing landscape that is the FDA. Using current regulations, our regulatory review will first analyze the mobile medical application's (MMA's) stance within the FDA and provide quality feedback on whether their product currently falls under FDA jurisdiction. Next, we will discuss potential FDA regulation, using draft guidance and other materials alluding to the FDA’s stance, which could bring the MMA into the guise of the FDA. Once we make our conclusions about regulation we then will inform the company about the costs associated with FDA compliance and approval and ways to mitigate those costs through implementing FDA mandated practices in the early stages of development. Finally, using data obtained through client interviews, we will offer best business practices and marketing strategies that will help alleviate the regulatory burden. This report will supply the start-up and any potential investors with the valuable information needed to prepare for the FDA, thus giving them a leg-up over their competitors and helping to create a sustainable and profitable business that will succeed despite regulation.
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Tenzing Group
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Pharmaceuticals & Biotechnology
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